(84 days)
The MAGNETOM Espree is indicated for use as magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Espree may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.
The MAGNETOM Espree System is a 1.5 T closed superconducting magnet designed scanner. It consists of the same types of hardware (with a modified gradient coil. RF body resonator and magnet) that is currently available with MAGNETOM Avanto.
The provided text describes a 510(k) summary for the Siemens MAGNETOM Espree System, a Magnetic Resonance Diagnostic Device (MRDD). However, it does not contain the level of detail requested for acceptance criteria, specific study results, or statistical data typically associated with performance evaluations for AI/CADe devices.
Here's an analysis based on the information provided, highlighting what is present and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists "Performance Levels" and "Action Levels" that the MAGNETOM Espree is expected to conform to, aligning with FDA guidance and NEMA/IEC standards. However, it does not provide specific quantitative acceptance criteria or the reported device performance measurements against these criteria.
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance |
|---|---|---|
| Action Levels | Maximum Static Field | Not specified quantitatively |
| Rate of Change of Magnetic Field | Not specified quantitatively | |
| RF Power Deposition | Not specified quantitatively | |
| Acoustic Noise Levels | Not specified quantitatively | |
| Performance Levels | Signal to Noise | Not specified quantitatively |
| Image Uniformity | Not specified quantitatively | |
| Geometric Distortion | Not specified quantitatively | |
| Slice Profile, Thickness and Gap | Not specified quantitatively | |
| High Contrast Spatial Resolution | Not specified quantitatively |
The document states: "The MAGNETOM Espree will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM Avanto." This indicates that the device will conform rather than has demonstrated specific conformity results in this summary document.
2. Sample Size Used for the Test Set and Data Provenance:
This information is not present in the provided text. The submission focuses on substantial equivalence to a predicate device (Siemens MAGNETOM Avanto) based on hardware and operational similarities and adherence to general safety and performance standards, rather than a clinical study evaluating diagnostic performance with specific test sets.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
This information is not present. As no specific diagnostic performance study on a test set is detailed, the concept of establishing ground truth by experts is not applicable in this document.
4. Adjudication Method for the Test Set:
This information is not present.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This information is not present. The document does not describe any study comparing human reader performance with or without AI assistance. This device is a foundational imaging system, not an AI/CADe diagnostic aid that augments human readers.
6. Standalone (Algorithm Only) Performance:
This information is not present. The MAGNETOM Espree is an MR imaging system that produces images for human interpretation, not an algorithm providing diagnostic outputs independently.
7. Type of Ground Truth Used:
This information is not present. Given the nature of the device as an imaging system and the focus on substantial equivalence, the document doesn't discuss diagnostic ground truth as would be relevant for a CADe/AI device.
8. Sample Size for the Training Set:
This information is not present. There is no mention of a "training set" as this device is not an AI/machine learning product that undergoes a training phase with a dataset.
9. How the Ground Truth for the Training Set Was Established:
This information is not present. This question is not applicable to the type of device and submission described.
In summary:
The provided 510(k) summary for the MAGNETOM Espree system demonstrates substantial equivalence to a predicate device (MAGNETOM Avanto) by highlighting similar hardware, intended use, and adherence to established safety and general performance standards (NEMA, IEC, FDA guidance for MRDDs). It does not provide details of specific clinical performance studies with acceptance criteria, test sets, or ground truth establishment as would be expected for AI/CADe devices or devices requiring specific diagnostic accuracy claims. The "study" referenced is the demonstration of conformity to recognized standards for the measurement of basic MRI performance and safety parameters, rather than a diagnostic accuracy trial.
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JUL 2 1 2004
Section 2: 510(k) Summary
Kof1112
SECTION 2: 510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.
I. General Information
| Establishment | Siemens Medical Solutions, Inc.51 Valley Stream ParkwayMalvern. PA 19355 |
|---|---|
| Registration Number | 2240869 |
| Manufacturer | Siemens AG. Bereich MedHenkestrasse 127D-91052 Erlangen. Germany |
| Registration Number | 8010024 |
| Contact Person | Ms. Nealie HartmanTechnical Specialist. Regulatory Submissions51 Valley Stream Parkway E50Malvern. PA 19355Phone: (610) 448-1769Fax: (610) 448-1787 |
| Device Name | Trade Name: MAGNETOM Espree SystemClassification Name: Magnetic Resonance Diagnostic DeviceCFR Code: 21 CFR § 892.1000Classification: Class II |
Performance Standards
None established under Section 514 the Food, Drug and Cosmetic Act.
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II. Safety and Effectiveness Information Supporting Substantial Equivalence.
Intended Use
The MAGNETOM Espree is indicated for use as magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Espree may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR safe biopsy needles.
Device Description
The MAGNETOM Espree System is a 1.5 T closed superconducting magnet designed scanner. It consists of the same types of hardware (with a modified gradient coil. RF body resonator and magnet) that is currently available with MAGNETOM Avanto.
Substantial Equivalence
The system is substantially equivalent to the following cleared medical devices:
| Predicate Device Name | FDA ClearanceNumber | FDA ClearanceDate |
|---|---|---|
| Siemens MAGNETOM Avanto | K032428 | October 16, 2003 |
General Safety and Effectiveness Concerns:
Operation of the MAGNETOM Espree System is substantially equivalent to the commercially available MAGNETOM Avanto. Specified by the FDA guidance document for MR Diagnostic Devices that will be evaluated, below are the safety parameter with the following levels:
Action Levels
- · Maximum Static Field
- · Rate of Change of Magnetic Field
- · RF Power Deposition
- · Acoustic Noise Levels
Performance Levels
- · Signal to Noise
- · Image Uniformity
- · Geometric Distortion
- · Slice Profile. Thickness and Gap
- · High Contrast Spatial Resolution
The MAGNETOM Espree will conform to the FDA recognized NEMA Standards for the measurement of performance and safety parameters and the international IEC standard for safety issues with Magnetic Resonance Imaging Devices. This will assure that the performance of this device can be considered safe and effective with respect to the currently available MAGNETOM Avanto.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 2 1 2004
Ms. Nealie Hartman Technical Specialist Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway MALVERN PA 19355
Re: K041112
Trade/Device Name: MAGNETOM Espree Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: 90 LNH and LNI Dated: April 26, 2004 Received: April 28, 2004
Dear Ms. Hartman:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) I ms lotter notification. The FDA finding of substantial equivalence of your device to a legally promaticated predicated device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dosh o spoolite at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx.1xxx | (301) 594-4597 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4697 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. brigden
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4: INDICATIONS FOR USE STATEMENT
510(k) Number (if known)______________________________________________________________________________________________________________________________________________________
Device Name: MAGNETOM Espree
Indications for Use:
The MAGNETOM Espree is indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, (MIOD) that produce trans spectra, and that display the internal structure and/or function of spectiossopic integoedialities. These images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
The MAGNETOM Espree may also be used for imaging during interventional procedures The MITORET ON ESPEC And as in room display as, in room display and MR safe biopsy needles.
(please do not write below this line- continue on another page if needed)
Concurrence of CDRH, Office of Device Evaluation
Prescription Use_ V
Over-The-Counter Use __
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number
CONFIDENTIAL
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.